Henry Schein
Alginate Dustless Spearmint Regular Set is a material for high precision printing, based on potassium alginate. Alginates are indicated for total or partial impressions of dentate and…
Alginate Dustless Spearmint Regular Set is a material for high precision printing, based on potassium alginate. Alginates are indicated for total or partial impressions of dentate and toothless mouths in work on total or partial removable prostheses in the making of study models for orthodontic works, also being useful in impressions for making single and multiple restorations, crowns and fixed bridges.
6manufacturers in China registered for this device type
164catalogue numbers in this listing
Who Else Makes It
Concentrated in Henan (1), Shandong (1), Jiangxi (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hygedent Inc. | Beijing | Beijing | Contract manufacturer | 1 |
| Zhengzhou Huaer Electro-Optics Technology Co., Ltd. | Zhengzhou | Henan | Contract manufacturer | 21 |
| Shandong Huge Dental Material Corporation | Rizhao | Shandong | Manufacturer | 17 |
| Jiangxi Dentalbright Technology Co., Ltd. | Jiujiang | Jiangxi | Contract manufacturer | 12 |
| Sunrise Dental Laboratory, Ltd. | Kowloon | Hong Kong | Manufacturer | 5 |
| Chemoment Materials Co., Ltd. | Hefei | Anhui | Manufacturer | 3 |
Record
| Listed by | Henry Schein, Inc., United States |
|---|---|
| FDA product code | ELW |
| Device type | Material, Impression |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3660 |
| 510(k) | K040053 |
| Record published | 2017-01-24 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Stored in a tightly closed container and protected from humidity and excessive heat |
| Packaging | Case of 10, shipper of 4, case of 20, case of 12, case of 6, case of 8 |
| Sizes | Weight 9 kg; weight 454 g; total volume 1 Fluid Ounce |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1016472 | Weight 9 kg | In distribution | |
| 5703045 | In distribution | ||
| 5703048 | In distribution | ||
| 5705729 | In distribution | ||
| 1012587 | Weight 454 g | In distribution | |
| 1025178 | 2 | In distribution | |
| 1026812 | In distribution | ||
| 5703006 | In distribution | ||
| 5702968 | In distribution | ||
| 1029937 | 4 | In distribution | |
| 1125807 | 2 | In distribution | |
| 5703037 | In distribution | ||
| 1026405 | 4 | In distribution | |
| 1005455 | Weight 454 g | In distribution | |
| 1065281 | In distribution | ||
| 5702967 | In distribution | ||
| 1012587 | Weight 454 g | In distribution | |
| 9004597 | In distribution | ||
| 1024749 | 4 | In distribution | |
| 5702976 | In distribution | ||
| 5702965 | In distribution | ||
| 5703025 | In distribution | ||
| 1024752 | 4 | In distribution | |
| 9001612 | In distribution | ||
| 1028752 | In distribution | ||
| 5701329 | In distribution | ||
| 1007001 | Total Volume 1 Fluid Ounce | In distribution | |
| 1016472 | Weight 9 kg | In distribution | |
| 5703016 | In distribution | ||
| 9004596 | In distribution | ||
| 5703042 | In distribution | ||
| 1072155 | 2 | In distribution | |
| 5703044 | In distribution | ||
| 1126240 | 8 | In distribution | |
| 5703026 | In distribution | ||
| 1126241 | 2 | In distribution | |
| 5703027 | In distribution | ||
| 1014564 | Weight 454 g | In distribution | |
| 1024809 | 4 | In distribution | |
| 1125966 | 4 | In distribution | |
| 1029130 | 4 | In distribution | |
| 9000600 | In distribution | ||
| 5703009 | In distribution | ||
| 1017036 | Weight 9 kg | In distribution | |
| 5703050 | In distribution | ||
| 1125974 | 4 | In distribution | |
| 1011906 | Weight 9 kg | In distribution | |
| 1005292 | Weight 454 g | In distribution | |
| 5703028 | In distribution | ||
| 1125992 | In distribution | ||
| 1017428 | Weight 9 kg | In distribution | |
| 9001613 | In distribution | ||
| 1066496 | In distribution | ||
| 1125993 | In distribution | ||
| 1025593 | 2 | In distribution | |
| 1024751 | 4 | In distribution | |
| 5703001 | In distribution | ||
| 5703033 | In distribution | ||
| 1126997 | 2 | In distribution | |
| 1034594 | In distribution | ||
| 5701327 | In distribution | ||
| 9001800 | In distribution | ||
| 5703030 | In distribution | ||
| 1124867 | 2 | In distribution | |
| 5702971 | In distribution | ||
| 1125970 | 4 | In distribution | |
| 1125969 | 4 | In distribution | |
| 5703002 | In distribution | ||
| 5702973 | In distribution | ||
| 1029357 | 2 | In distribution | |
| 1015208 | In distribution | ||
| 1066120 | In distribution | ||
| 5703031 | In distribution | ||
| 1026150 | 4 | In distribution | |
| 5702977 | In distribution | ||
| 5702994 | In distribution | ||
| 5702972 | In distribution | ||
| 5705727 | In distribution | ||
| 5702974 | In distribution | ||
| 5703012 | In distribution | ||
| 1017036 | Weight 9 kg | In distribution | |
| 1025276 | In distribution | ||
| 5703052 | In distribution | ||
| 5703024 | In distribution | ||
| 5703017 | In distribution | ||
| 1005292 | Weight 454 g | In distribution | |
| 1024779 | 2 | In distribution | |
| 5703051 | In distribution | ||
| 1066726 | In distribution | ||
| 1027724 | 4 | In distribution | |
| 5703015 | In distribution | ||
| 5703000 | In distribution | ||
| 5705728 | In distribution | ||
| 1126996 | 2 | In distribution | |
| 1023597 | 2 | In distribution | |
| 5703011 | In distribution | ||
| 1066228 | In distribution | ||
| 1029074 | 4 | In distribution | |
| 5703040 | In distribution | ||
| 5703041 | In distribution | ||
| 1014564 | Weight 454 g | In distribution | |
| 5703034 | In distribution | ||
| 1125806 | 2 | In distribution | |
| 1029398 | 4 | In distribution | |
| 5702991 | In distribution | ||
| 1125968 | 4 | In distribution | |
| 1125965 | 2 | In distribution | |
| 1017428 | Weight 9 kg | In distribution | |
| 5703043 | In distribution | ||
| 1125967 | 4 | In distribution | |
| 5702966 | In distribution | ||
| 5705725 | In distribution | ||
| 5703007 | In distribution | ||
| 5703032 | In distribution | ||
| 9004607 | 8 | In distribution | |
| 5702995 | In distribution | ||
| 5703005 | In distribution | ||
| 1011906 | Weight 9 kg | In distribution | |
| 5702993 | In distribution | ||
| 5703014 | In distribution | ||
| 5702969 | In distribution | ||
| 5703013 | In distribution | ||
| 5720877 | In distribution | ||
| 1125971 | 4 | In distribution | |
| 5703046 | In distribution | ||
| 5703029 | In distribution | ||
| 5703036 | In distribution | ||
| 1027252 | 4 | In distribution | |
| 5720875 | In distribution | ||
| 1125483 | 2 | In distribution | |
| 1073642 | 2 | In distribution | |
| 5702990 | In distribution | ||
| 5703010 | In distribution | ||
| 5703039 | In distribution | ||
| 5703049 | In distribution | ||
| 5702989 | In distribution | ||
| 5701326 | In distribution | ||
| 5702975 | In distribution | ||
| 1025073 | 4 | In distribution | |
| 1066423 | In distribution | ||
| 5703047 | In distribution | ||
| 1005455 | Weight 454 g | In distribution | |
| 5720876 | In distribution | ||
| 5703038 | In distribution | ||
| 5701328 | In distribution | ||
| 5720873 | In distribution | ||
| 1023434 | 4 | In distribution | |
| 5720874 | In distribution | ||
| 5703004 | In distribution | ||
| 5702998 | In distribution | ||
| 5702997 | In distribution | ||
| 5702996 | In distribution | ||
| 5702970 | In distribution | ||
| 5703023 | In distribution | ||
| 5703035 | In distribution | ||
| 5702988 | In distribution | ||
| 5702992 | In distribution | ||
| 1026064 | 4 | In distribution | |
| 5720878 | In distribution | ||
| 5703008 | In distribution | ||
| 5703003 | In distribution | ||
| 5702999 | In distribution | ||
| 1125973 | 4 | In distribution | |
| 1027196 | 4 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 124 |
| EXAlence™ | GC America Inc. | 96 |
| MARK3 | Cargus International, Inc | 75 |
| Panasil | Kettenbach Gmbh & Co KG | 73 |
| Aquasil Ultra Smart Wetting® Impression Material Cartridge System | Dentsply LLC | 72 |
| DentMix | IPB Inc | 70 |
| Affinis | Coltène/Whaledent AG | 67 |
| Take 1 Advanced | Kerr Corporation | 54 |
| MDC Dental | MDC Dental | 49 |
| Elastomeric Impression Material | Shandong Huge Dental Material Corporation | 46 |
| Splash® | DEN-MAT Holdings, LLC | 44 |
| Futar | Kettenbach Gmbh & Co KG | 42 |
Showing 12 of 1,245. All products under Material, Impression
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.